Model Number N/A |
Device Problem
Output Problem (3005)
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Patient Problems
No Information (3190); No Code Available (3191)
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Event Date 06/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during a knee arthroplasty utilizing the robotically assisted surgical system, rosa, the tibial cut was reported to be too varus.The tibia was re-cut using standard instrumentation.No additional patient consequences were reported.
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Manufacturer Narrative
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The reported event could not be confirmed.The log files investigation revealed that no varus/valgus discrepancy was found between the intra-operative plan and validation for all the cuts performed with rosa robot system.Applicative tests were performed during preventive maintenance with no issues found; the functionality and accuracy of rosa knee platform device history record was reviewed and no discrepancies relevant to the reported event were found.The device functioned as intended.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information reported.
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Search Alerts/Recalls
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